The US Food and Drug Administration (FDA), in early January 2025, published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The Agency recommends taking a total product lifecycle (TPLC) approach to the products to ensure they meet their expectations for safety and efficacy.
FDA’s unpopular LDT final rule could meet its maker when the president-elect hits the oval office, but how is he most likely to upend it?
Officials at the United States Food and Drug Administration (FDA) are reportedly planning to reduce the number of routine inspections carried out by the Office of Inspections and Investigations (OII) after last week’s layoffs due to steep layoffs week in support staff, according to a report late last week by CBS News.
The protective power of genetic mutations discovered in naturally short sleepers: The identification of genetic mutations in natural short sleepers, individuals genetically predisposed to require significantly less sleep without negative health effects, opens the possibility for personalized sleep interventions that could improve health outcomes and quality of life. Recent research indicates that natural short sleepers might effectively clear brain toxins linked to neurodegenerative diseases like Alzheimer’s, suggesting these mutations might offer protective effects.
Alabama woman receives pig kidney transplant: Towana Looney, a 53-year-old from Alabama, became the first living person to receive a kidney transplant from a new type of genetically modified pig in an operation at New York University Langone Health. The FDA has previously allowed transplants of genetically modified pig kidneys and hearts into critically ill patients, who only survived for a short period; however, doctors are more optimistic about Looney’s prognosis due to her healthier condition.
Health and Human Services (HHS) layoffs more employees, shutters offices: HHS has started sending layoff notices that could affect up to 10,000 employees in addition to those who have already left as part of a major reorganization. The workforce reduction and reorganization plan includes consolidating certain Agencies and creating the Administration for a Healthy America. Key leaders at the NIH and FDA have been dismissed or placed on leave, while the CDC is expected to face a significant reduction in staff, particularly in areas not directly related to infectious diseases.
Paul Simon finds hope in animal research for hearing recovery: Musician Paul Simon is seeking scientific remedies for his hearing loss by engaging with researchers at the Stanford Initiative to Cure Hearing Loss, exploring how animals such as zebrafish and mice can regenerate ear hair cells. Researchers are working on gene therapy and drug solutions that could potentially reverse hearing damage.
Researchers develop new antibiotics to tackle superbugs: Researchers have developed 30 new antibiotics to combat superbugs, after extensive research on over 700 variations. This development is crucial for conditions like diabetic foot infections, which often lead to amputations, and the researchers are now seeking funding to ensure these drugs’ safety and efficacy.
Injection offers hope for asthma and COPD patients: A study in Lancet Respiratory Medicine showcased a promising new treatment for asthma and chronic obstructive pulmonary disease using benralizumab injections, demonstrating that a single injection during flare-ups is more effective than conventional steroid tablets, marking the first major advancement in 50 years. Benralizumab injections reduced the need for additional interventions by 30% and showed fewer symptoms and treatment failures, suggesting that the antibody injection could be a safer alternative to steroids, which have serious side effects.
New schizophrenia drug shows promise for other brain disorders: KarXT, a new schizophrenia drug with a novel mechanism targeting muscarinic receptors, has sparked interest in its potential to treat Alzheimer’s disease, bipolar disorder and addiction, though real-world effectiveness and side effects are concerns. Xanomeline, one of KarXT’s components, primarily affects the M1 and M4 muscarinic receptors, with research showing M4 linked to antipsychotic effects and M1 linked to cognition, prompting researchers to explore targeted therapies that could offer greater benefits with fewer side effects.